PDA TR 56-2012 (R2016)

Application of Phase-Appropriate: Quality System and cGMP to the Development of Therapeutic Protein Drug Substance (API or Biological Active Substance)

The scope of this technical report covers phase-appropriate Current Good Manufacturing Practices (CGMP) during the manufacturing of therapeutic protein drug substance (biological active substance) from the R&D stage through completion of Phase 3 clinical trials. The scope also includes implementation of a pharmaceutical quality system that ensures the safety and quality of products intended for use in clinical trials. Finally, it provides the basis for subsequent assurance of the equivalence of products used in trials to products submitted for marketing approval. This report will focus on current best practices.

Parenteral Drug Association [pda]

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